Senior Project Specialist

2 days ago

Ballina, Mayo County, Ireland beBeeProject Full time €65,432 - €123,456
Job Title: Senior Project Specialist

The role of a Senior Project Specialist is to oversee and lead cross-functional project teams in delivering processing equipment on time and within scope. This encompasses a range of equipment, including autoclaves, RABS & isolator filling machines, LAF units, compounding skids, vessels, containment booths, and stopper processing equipment.

  • Safely coordinate and lead cross-functional project teams to deliver processing equipment on schedule and within budget requirements. This encompasses a range of equipment, including autoclaves, RABS & isolator filling machines, LAF units, compounding skids, vessels, containment booths, and stopper processing equipment.
  • Develop user requirement specifications to ensure clarity and effectiveness for all stakeholders involved.
  • Prepare and execute Requests for Change (RCEs), place orders, manage project schedules, and conduct design review meetings with the project team and key stakeholders.
  • Ensure compliance with ASME BPE standards and relevant ISPE guidelines throughout the project lifecycle.
  • Coordinate the installation and services hook-up of processing equipment, collaborating closely with equipment vendors and engineering personnel.
  • Lead project team participation in Factory Acceptance Testing (FAT) programs to verify that equipment meets the required specifications and standards.
  • Oversee documentation requirements for all equipment, ensuring seamless handovers and transition of knowledge from one team member to another.
  • Provide commissioning support and engineering expertise during qualification phases to ensure smooth operations and efficient process execution.
  • Collaborate with E&T Senior Managers, System Owners, and Project Teams to achieve shared goals and objectives.

Requirements:

  • A third-level qualification in an engineering discipline or equivalent experience is essential to excel in this role.
  • Substantial experience working in biologics, pharmaceuticals, or medical device industries, with a minimum of 2-5 years' experience in a similar position.
  • Proven project management expertise with a strong track record of delivering results and meeting project deadlines.
  • Strong self-motivation and technical acumen are vital for success in this role, allowing you to work independently and make informed decisions.
  • Excellent communication and interpersonal skills are required to operate effectively within multi-functional project teams and collaborate with members from diverse disciplines and functions across the project.
  • Ability to work autonomously and articulate specific functional requirements for all aspects of the project, while collaborating with members from diverse disciplines and functions across the project.
  • Strong leadership skills and ability to collaborate closely with other departments within an organization to achieve shared goals and objectives.

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